FDA Medical Device Recalls (openFDA)
Materialise N.V.: ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
- Recall number
- Z-2287-2023
- Recalling firm
- Materialise N.V.
- Product
- ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
- Status
- Completed
- Initiated
- 2023-06-19
- Posted
- 2023-08-03
- Terminated
- not on file
- Reason
- Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- Root cause
- Process change control
- Action
- Synthes sales representative was made aware of the issue on 19 June 2023, by phone and email. Materialise requested the product to be returned on 19 June 2023, Synthes sales representative confirmed that surgery will be performed without guides and will return the case. The guides were returned/received at Materialise on 23 June 2023.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Lot, serial or model codes
- UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
- 510(k) numbers
- ["K103136"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3003998208
- Firm city
- Heverlee
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28